Medically reviewed by Drugs.com. Last updated on Jun 1, 2023.
Applies to the following strengths: 8 mg; 4 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Benign Prostatic Hyperplasia
8 mg orally once a day with a meal
Comments: Patients who have difficulty swallowing may open the capsule and sprinkle the powder on a tablespoonful of applesauce. The applesauce should not be hot, and should be soft enough to be swallowed within 5 minutes without chewing and followed with 8 ounces of cool water.
Renal Dose Adjustments
Mild renal dysfunction (CrCl 50 to 80 mL/min): No adjustment recommended
Moderate renal dysfunction (CrCl 30 to 50 mL/min): 4 mg orally once a day with a meal
Severe renal dysfunction (CrCl less than 30 mL/min): Contraindicated
Liver Dose Adjustments
Mild to moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction (Child-Pugh 10 or greater): Contraindicated
US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides
- Hypersensitivity to the active component or any of the ingredients
- Severe renal impairment (CrCl less than 30 mL/min)
- Severe hepatic impairment (Child-Pugh 10 or greater)
- Concomitant use of strong CYP450 3A4 inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir)
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
- Inform patients regarding postural hypotension and related symptoms such as dizziness. Caution patients about driving, operating machinery, or performing hazardous tasks when initiating therapy.
- Inform patients that the most common adverse reaction, orgasm with reduced or no semen, does not pose a safety concern and is reversible upon discontinuation of this drug.
- Advise patients planning cataract surgery or other eye procedures to inform their ophthalmologist regarding use of this drug, even if they are no longer taking it.
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